GENERIC NAME OF THE MEDICINAL PRODUCT:

Lacosamide Tablet USP 50mg
Lacosamide Tablet USP 100mg
Lacosamide Tablet USP 150mg
Lacosamide Tablet USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Lacosamide Tablet USP 50mg
Each Filmed coated Tablet contains:
Lacosamide USP……………50mg
Excipients……………………Q.s.
Colurs: Ponceau 4R

b) Lacosamide Tablet USP 100mg
Each Filmed coated Tablet contains:
Lacosamide USP……………100mg
Excipients……………………Q.s.
Colurs: Quinoline Yellow Lake

c)Lacosamidea Tablet USP 150mg
Each Filmed coated Tablet contains:
Lacosamide USP……………150mg
Excipients……………………Q.s.
Colurs: Erythrosine Lake

d)Lacosamide Tablet USP 200mg
Each Filmed coated Tablet contains:
Lacosamide USP……………200mg
Excipients……………………Q.s.
Colurs: Sunset Yellow

THERAPEUTIC INDICATIONS:

Lacosamide is used to control partial onset seizures (seizures that involve only one part of the brain) in adults and children 1 month of age and older.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Lacosamide Tablet USP 50mg Technical Specification:

Product Name:
 Lacosamide Tablet USP
Brand Name: Generics
Strength: (50mg), (100mg), (150mg), (200mg)
Dosage Form: Tablet (Film coated)
Route of Administration: Via oral Route
Packing: 30s, 90s,100s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-Epileptic
Indication: Lacosamide is used to control partial onset seizures (seizures that involve only one part of the brain) in adults and children 1 month of age and older.
Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Lacosamide Tablet USP 50mg
  • Lacosamide Tablet USP 100mg
  • Lacosamide Tablet USP 150mg
  • Lacosamide Tablet USP 200mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Lacosamide Tablet USP 50mg
    Each Filmed coated Tablet contains:
    Lacosamide USP……………50mg
    Excipients……………………Q.s.
    Colurs: Ponceau 4R
  • b) Lacosamide Tablet USP 100mg
    Each Filmed coated Tablet contains:
    Lacosamide USP……………100mg
    Excipients……………………Q.s.
    Colurs: Quinoline Yellow Lake
  • c)Lacosamidea Tablet USP 150mg
    Each Filmed coated Tablet contains:
    Lacosamide USP……………150mg
    Excipients……………………Q.s.
    Colurs: Erythrosine Lake
  • d)Lacosamide Tablet USP 200mg
    Each Filmed coated Tablet contains:
    Lacosamide USP……………200mg
    Excipients……………………Q.s.
    Colurs: Sunset Yellow

THERAPEUTIC INDICATIONS:

  •  Lacosamide is used to control partial onset seizures (seizures that involve only one part of the brain) in adults and children 1 month of age and older.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.
  • Dosage:As directed by the Physician.
Attach dispensing label as per end county.